METOCLOPRAMIDE-WGR

What it is

Metoclopramide-WGR contains metoclopramide hydrochloride anhydrous. The medicine is available as 5 mg and 10 mg film-coated tablets.

Approved indications

Adults aged 20 years and over may use Metoclopramide-WGR as an adjunct to X-ray examination of the stomach and duodenum, to assist in intestinal intubation, and to control nausea and vomiting associated with intolerance to essential drugs possessing emetic properties, uraemia, radiation sickness, malignant disease, postoperative vomiting, labour, and infectious diseases. Metoclopramide-WGR has been found useful in the management of gastric retention after gastric surgery. Metoclopramide-WGR may be useful in the treatment of diabetic gastroparesis of mild to moderate severity. Young adults aged 15–19 years should use Metoclopramide-WGR only as second line therapy in severe intractable vomiting of known cause, vomiting associated with radiotherapy and intolerance to cytotoxic drugs, and as an aid to gastrointestinal intubation.

Dosing overview

Total daily dosage of Metoclopramide-WGR, especially in children and young adults, should not normally exceed 0.5 mg/kg bodyweight with a maximum of 30 mg daily. Maximum recommended treatment duration is 5 days in all age groups. In patients with clinically significant renal or hepatic impairment, therapy should be initiated at half the recommended dose.

Key safety warnings

Tardive dyskinesia may appear in some patients on long-term therapy or after drug therapy has been discontinued, with risk appearing greater in elderly patients on high dose therapy, especially females, and the symptoms being persistent and often irreversible. Prolonged treatment greater than 12 weeks with metoclopramide should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risks of developing tardive dyskinesia. Dystonic reactions occur in approximately 1% of patients given metoclopramide hydrochloride, occurring more frequently in children and young adults and may occur after a single dose. Very rare occurrences of Neuroleptic Malignant Syndrome have been reported, which is potentially fatal and comprises hyperpyrexia, altered consciousness, muscle rigidity, autonomic instability and elevated levels of CPK. Metoclopramide-WGR elevates prolactin levels, and tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro, a factor of potential importance if prescription is contemplated in a patient with previously detected breast cancer. Metoclopramide-induced depression has been reported in patients without a prior history of depression, and should only be given to patients with a prior history of depression if the expected benefits outweigh the potential risks.

Contraindications

Metoclopramide-WGR should not be used when stimulation of gastrointestinal motility might be dangerous, such as in the presence of gastrointestinal haemorrhage, mechanical obstruction, or perforation. Metoclopramide-WGR should not be used in phaeochromocytoma because the drug may cause a hypertensive crisis. Metoclopramide-WGR is contraindicated in patients with known hypersensitivity or intolerance to the drug. Metoclopramide-WGR is contraindicated in porphyria. Metoclopramide-WGR should not be used in epilepsy as it may increase the frequency and severity of seizures. Metoclopramide-WGR tablets should not be used in children below 15 years of age.

Regulatory history

Metoclopramide-WGR metoclopramide hydrochloride 5 mg and 10 mg film-coated tablets were first listed on the Australian Register of Therapeutic Goods on 17 December 2015. A 10 mg bottle formulation was added on 4 May 2016.